FDA Finalizes Custom Device Guidance Document

On September 24, 2014, FDA finalized its guidance document, “Custom Device Exemption,” which explains FDA’s interpretation of the new custom device requirements implemented as part of the Food and Drug Administration Safety and Innovation Act ("FDASIA"). We previously posted on the FDASIA requirements and FDA’s draft guidance on this topic here and here.

We will not repeat here the requirements to meet the custom device exemption, but will again note how limited this exemption will be. FDA expresses this view in the guidance by stating that, under the revised FDASIA provision, “as under the original custom device exemption, custom devices should represent a narrow category for which, due to the rarity of a patient’s medical condition or physician’s special need, compliance with premarket review requirements and performance standards under section 514 and 515 of the FD&C Act is impractical.” Guidance, at 2.

For the most part, the draft and final guidances are largely similar. A few exceptions are as follows:

The final guidance includes a question asking whether, if a patient needs to undergo revision surgery to replace a component of her implant that is no longer being manufactured, the component is a custom device. The guidance states that the component would only be a custom device “if it is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat and meets all the other requirements of section 520(b). That the component is no longer being manufactured does not make the component a custom device. However, under these circumstances, a compassionate use request to allow the component to be manufactured and implanted could be submitted to FDA.” Guidance at 7. It is not clear why a manufacturer would need to seek a compassionate use request from FDA to replace a component that was previously manufactured and, presumably, was itself cleared or approved or was part of a cleared or approved medical device. So long as the clearance or approval covering the component is still valid (e.g., has not been withdrawn), the manufacturer should not need to seek permission from FDA to manufacture the component.

As noted in our prior blog post, the draft guidance did not provide any examples of potential “physician-centric” custom devices; all the examples were patient-centric. In the final guidance, FDA states that in the comments received about the draft, it did not receive any examples describing a potential physician-centric custom device. The final guidance states: “Assuming all other aspects of the custom device exemption in the FD&C Act are met, a potential example of a physician-centric medical device could be one for a surgical instrument requiring premarket review that needs to be modified to accommodate a deformity of a surgeon’s hand.” Guidance, at 9.

The draft guidance modifies the advice regarding submission of electronic copies of the annual report. The draft guidance stated that one or both copies could be submitted electronically to customdevices@fda.hhs.gov. The final guidance, however, states that at least one of the two required copies must be a hard copy, and encourages that the second copy be an eCopy provided on a CD, DVD, or flash drive. Both the hard copy and eCopy will need to be sent to a physical address; the final guidance does not include the email address provided in the draft as a submission method. The final guidance also states that the submission of the eCopy should be done in accordance with the guidance document, “eCopy Program for Medical Device Submissions.” Being required to submit one hard copy and follow the eCopy guidance is more burdensome to submitters than being able to submit two electronic copies via email.

The final guidance, like the draft, does a good job of explaining how FDA will interpret the custom device exemption. And the final guidance, like the draft, indicates FDA’s intent to restrict use of the custom device exemption as much as possible.